The following data is part of a premarket notification filed by General Biometrics, Inc. with the FDA for Immunodot Thyroid Autoimmunity Panel.
Device ID | K903843 |
510k Number | K903843 |
Device Name: | IMMUNODOT THYROID AUTOIMMUNITY PANEL |
Classification | Immunochemical, Thyroglobulin Autoantibody |
Applicant | GENERAL BIOMETRICS, INC. 15222 Avenue Of Science Suite A San Diego, CA 92128 |
Contact | Bryan L Kiehl |
Correspondent | Bryan L Kiehl GENERAL BIOMETRICS, INC. 15222 Avenue Of Science Suite A San Diego, CA 92128 |
Product Code | JNL |
CFR Regulation Number | 866.5870 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-08-21 |
Decision Date | 1990-10-02 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00613745058894 | K903843 | 000 |
00613745058252 | K903843 | 000 |
00613745039121 | K903843 | 000 |